HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive. The primary goal of this study is to define the intra-individual reproducibility of the HepQuant tests, that is, to see if a person is given the tests several times that the test results are essentially the same each time. Subjects for this study will include healthy controls and patients with chronic liver diseases. The chronic liver diseases will include hepatitis C virus (HCV) infection and a serious form of fatty liver disease, known as non-alcoholic steatohepatitis (NASH). The HCV and NASH patients will include men and women, and those with early stage and late stage liver disease as defined by the amount of fibrosis observed in their liver biopsies. Once a subject has been enrolled in the study they will be given the HepQuant tests on three separate days within the span of one month. The hypothesis of this study is that HepQuant tests will reproducibly report liver function in healthy controls and patients with all stages of chronic HCV and NASH liver disease and that liver function will decrease as the amount of liver fibrosis increases in the chronic liver disease patients.

The Cholate Shunt Test result is defined as the ratio of the IV Cholate Clearance Test result to the Oral Cholate Clearance Test result and is expressed as a percentage. The IV Cholate Clearance Test result = (dose cholate-24-13C/AUC cholate-24-13C)/subject weight and is expressed as mL/min/kg. The Oral Cholate Clearance Test result = (dose cholate-2,2,4,4-d4/AUC cholate-2,2,4,4-d4)/subject weight and is expressed as mL/min/kg. The AUC cholate-24-13C and AUC cholate-2,2,4,4-d4 are calculated from LCMS analysis of serum samples collected at 0, 5, 20, 45, 60, 90 minutes post-dose.

The intra-individual reproducibility of each cholate test, the IV Cholate Clearance Test, the Oral Cholate Clearance Test, and the Cholate Shunt Test, will be defined by its average Coefficient of Variation (CV) and its Intra-Class Correlation (ICC). Each subject will be tested at baseline and then twice more on separate days within the span of one month. The CV of each subject's three replicate tests will be used to calculate the average CV for each type of test. All test results for each type of test will be used to calculate its ICC.

The correlation of each of the cholate test results with the histological fibrosis stage in chronic HCV patients will be determined by Pearson correlations and expressed by p values and r2 values. The correlation of the cholate test results with the histological fibrosis stage in NASH patients will be determined in the same manner.

Healthy controls will be recruited to have approximately equal numbers of men and women. Controls will be of healthy weight as defined by a BMI 18-25 and without liver disease or risk factors for liver disease.

Device: Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:

Pregnancy or intent to become pregnant. Urine pregnancy tests will be performed at each visit.

Inability to consent for one's self

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01579162